PACKAGING OF TABLETS: TYPES, MATERIALS AND QC.

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PACKAGING OF TABLETS: TYPES, MATERIALS AND QC.

  1. 1. PACKAGING OF TABLETS: TYPES, MATERIALS AND QC. PRESENTED BY: AKSHAY JOSHI M.PHARM SEM II GUIDED BY: DR. A.R MADGULKAR. Principal: AISSMS COP, PUNE. 1
  2. 2. CONTENTS  Introduction  Characteristics  Types of Packaging.  Quality Control  Packaging Development  Summary  References 2
  3. 3. INTRODUCTION:  Packaging is the science, art and technology of enclosing or protecting products.  Packaging can be described as a coordinated system of preparing goods for transport, warehousing, storage, sale, and end use. 3
  4. 4. NEED OF PACKAGING  Physical protection  Barrier protection  Agglomeration  Security  Convenience  Dose control 4
  5. 5. PACKAGING IS A BRIDGE PRODUCTION MARKETING 5
  6. 6. CHARACTERISTICS Protection From Environmental Conditions Non-reactive With The Product  Not Impart Taste Or Odor to the Product  Non-toxic, Adoptable To Commonly Employed High Speed Packaging Equipments Meet Applicable Tamper Resistance Requirements 6
  7. 7. PACKAGING TYPES:  Primary packaging is the material that first envelops the product and holds it. 7
  8. 8.  Secondary packaging is outside the primary packaging –used to group primary packages together 8
  9. 9.  Tertiary packaging is used for bulk handling , warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into containers. 9
  10. 10. 10 Requirements of pharmaceutical packaging Easy dispensing Child resistance Senior friendliness Hermetically Sealed Modularized machinery 11
  11. 11. TYPES OF PACKAGING. Strip packaging. Bottle packaging. 11
  12. 12. BLISTER PACKAGING:  Blister packaging is a type of pre-formed plastic packaging used for small consumer goods.  The two primary components of a blister pack are the cavity made from either plastic or aluminium - and the lidding, made from, paper, plastic or aluminium.  The cavity contains the product and the lidding seals the product in the package. 12
  13. 13. ADVANTAGES: Product Integrity Product Protection Tamper Evidence Reduced Possibility of Accidental Misuse Patient Compliance. 13
  14. 14. Blister packaging Thermo foaming Transparent Amber Cold foaming Alu-Alu 14
  15. 15. BLISTER PACKING COMPONENT The four basic components of pharmaceutical blister packages are; 1. The forming film (Forming films account for approximately 80–85% of the blister package) 2. The lidding material (lidding materials make up 15–20% of the total weight of the package.) 3. Heat seal coating 15
  16. 16. THERMOFORMABLE MATERIAL Forming film: ―The forming film is the packaging component that receives the product in deep drawn pockets.‖ One key to package success is selecting the right plastic film for the blisters in terms of its; 1. Property/ type, 2. Grade, 3. Thickness.  For example, monolayer PVC film, PVC/PVDC duplex, PVC/PE/PVDC triplex and PVC/ALCAR laminate. 16
  17. 17. MONOLOYER POLY(VINYL CHLORIDE) PVC  Rigid PVC.  Very clear, stiff material with a low WVTR.  Excellent thermoformability.  Low permeability.  Low cost.  Good chemical resistance.  Pvc films that are thermoformed have a thickness of about 10–15 mm. 17
  18. 18. POLYVINYLIDENE CHLORIDE (PVDC)–COATED PVC.  PVDC is the most common coating in blister packaging because it can reduce the gas and moisture permeability of PVC blister packages by a factor of 5–10.  Coated PVC films have a thickness of 8–10 mil; the thickness of the PVDC coat amounts to 1–2 mil.  The coating is applied on one side and usually faces the product and the lidding material. 18
  19. 19.  Excellent oxygen and moisture barrier properties as compared to normal PVC film.  Good thermoformability; PVDC is very cost- effective, as coating weight can be customized depending on the requirements of the barrier properties.  Medical grade and non-toxic.  High levels of transparency which improves the aesthetics of the product. 19
  20. 20. PVC/CHLOROTRIFLUOROETHYLENE (CTFE).  Films made from PVC and CTFE have the lowest water-vapour permeability of all films used for blister packaging.  When compared with the water-vapor permeability of 10-mil PVC, the permeability of 8-mil PVC/0.76- mil CTFE is lower by a factor of 15.  However, the environmental concerns regarding PVC also apply to PVC/CTFE films. 20
  21. 21. POLYSTYRENE (PS)  Polystyrene (PS) is perfectly compatible with thermoforming, but its high water vapor permeability makes it unsuitable as a blister material for pharmaceutical purposes. 21
  22. 22. ALUMINIUM BLISTER FOIL  Used in cold foaming technique.  Alu alu packaging.  Good barrier to moisture, vapour and gases.  20 to 25 micron thick. 22
  23. 23. VIDEOS:  Lovell Industries - Blister Packaging South Africa Animation.mp4  DPP-250F blister machine for tablet- Carlos.mp4 23 Fig 2: Blister machine
  24. 24. LIDDING MATERIAL: ―The lidding material provides the base or main structural component upon which the final blister package is built‖ After the tablets have been properly fed to the preformed support materials the lidding material is sealed onto the support material. Temperatures for this can range from 140-300 C. 24
  25. 25.  Lidding materials can also use soft (annealed) foil (0.025 mm) or laminations of soft foil and other substances (tissue paper).  Soft and embossed soft foil extends in the push-through stage, hence may give added child safety provided it does not damage the item concerned. 25
  26. 26. It must be selected according to; The size,  Shape, Weight of the product Style of the package to be produced. 26
  27. 27.  An essential component of lidding material is the sealing coating.  The side of the lidding material that faces the product and the forming film must be provided with a coating material suitable for heat sealing.  This is usually accomplished by means of a heat sealing lacquer  An additional requirement is that the sealing strength must fall within a predetermined tolerance. 27
  28. 28. ALUMINIUM  Push-through, peelable, peel-push, tear- open and child resistant options.  Tailored solutions for new therapies, new processes and special applications.  Push-through foil in gauges 15-30 μm, hard or soft tempered.  Peelable opening in gauges 20 and 25 μm soft, laminated with PET or paper/PET.  Heat sealable (push-through and peelable foil) to PVC, PVdC, PP, PET and PE; 28
  29. 29. KEY BENEFITS  Broad product range serving all your application needs and optimising speed-to- market  Efficiency on blister lines guaranteed with proven processability  Optimal barrier properties provided by aluminum foil  High performance ensured by optimised sealing to thermoformed films. 29
  30. 30. PAPER-ALUMINUM.  In Europe, the thickness of the aluminum typically is 0.28–0.48 mil, but in the United States it has a thickness of 0.6–1 mil. 30
  31. 31. PAPER/PET/ALUMINUM.  Lidding material made of a paper/PET/aluminum laminate is often called peel off–push through foil.  The concept is to first peel off the paper/PET laminate from the aluminum and then to push the tablet through the aluminum. 31
  32. 32. ALU-ALU STRIP  Blister Packing contain PVC foil (0.25mm) and Alu. foil (0.025mm)  Strip Packing contain Both side Poly alu. foil (0.30mm) 32
  33. 33. BOTTLES 33
  34. 34. COMMENLY USED MATERIALS:  Glass – type III (solids)  Plastic – low density polyethylene (LDPE) – high density polyethylene (HDPE) – polypropylene (PP) – polyester PET, – Cyclo-olefin copolymer (COC) 34
  35. 35. GLASS  Widely used.  Advantages of glass: •It allows easy inspection of the containers contents •variable shapes.  Disadvantage of glass: • It is fragile • It is expensive when compared to the price of plastic 35
  36. 36. GLASS COMPOSITION Silica (SiO2) 59-75 % Calcium oxide (CaO) 5-12 % Sodium oxide (Na2O) 12-17 % Alumina (Al2O3) 0.5-3.0 % Other oxide : Barium oxide (BaO) Boric oxide (B2O2) Potassium oxdie (K2O) Magnesium oxide (MgO) 36
  37. 37. TYPES OF GLASS: Type I Glass Neutral glass, with a high hydrolytic resistant due to the chemical composition of the glass itself. Type II Glass Usually of soda-lime-silica glass with a high hydrolytic resistance resulting from suitable treatment of the surface. Type III Glass Soda-lime glass usually of soda-lime- silica glass with only moderate hydrolytic resistance. Type IV Glass Non parentral. 37
  38. 38. PLASTIC: LDPE.  It is a thermoplastic made from the monomer ethylene.  Density range of 0.910–0.940 g/cm3.  Not reactive at room temperatures, (except by strong oxidizing agents).  No branching.  Withstand temperatures of 80 c continuously.  Made in translucent or opaque variations. 38
  39. 39. HDPE:  Polyethylene thermoplastic made from petroleum.  Known for its large strength to density ratio.  HDPE is commonly used in the production of plastic bottles.  Although the density of HDPE is only marginally higher than that of low-density polyethylene, HDPE has little branching, giving it stronger intermolecular forces and tensile strength than LDPE.  Harder and more opaque and can withstand somewhat higher temperatures (110 C continuously) 39
  40. 40. POLYPROPYLENE  An addition polymer made from the monomer propylene.  it is rugged and unusually resistant to many chemical solvents, bases and acids.  Has an intermediate level of crystallinity between that of low- density polyethylene (LDPE) and high-density polyethylene (HDPE).  Tough and flexible, especially when copolymerized with ethylene. 40
  41. 41. VIDEO  Tablet Counter Packaging Line(Kwang Dah)..mp4 41
  42. 42. SECONDARY PACKAGING:  Labels and leaflets  Wrapping materials  bags and sacks  collapsible and rigid cartons and boxes  moulded pulpboard containers  paper liners, linings and laminations. 42
  43. 43. PAPER:- This can be used as a flexible wrap for products, or as a closure material for jars. Most paper materials are used with a liner applied either as a laminate or as a coating.  Paper and board are seen as renewable resources as distinct from petroleum- and metal-based resources.  They are not as consistent as synthetic products.  Hence, analyzing them is a problem.  Holocellulose  Lignin 43
  44. 44.  Holocellulose—this is 70–80% of the wood. It is the whole water-insoluble carbohydrate fraction comprising:  alpha-cellulose,  hemi-cellulose,  beta-cellulose,  gamma-cellulose,  Lignin—this varies between 17% and 30% of the bulk and is an amorphous phenylpropane polymer which is found 44
  45. 45. 45
  46. 46. QUALITY CONTROL FOR TABLET PACKAGING:  Softening and disaggregation (mechanical corrosion)  Chemical hydrolysis of the active ingredients (decrease of potency and/or forming of toxic compounds)  Oxidation of the active ingredients (decrease of potency and/or forming of toxic compounds)  Worst case, fatality can be the result of decomposition of the product. 46
  47. 47. WATER VAPOR TRANSMISSION RATE  Water Vapor Transmission rate is a measure of the passage of water vapor through a membrane.  It is the rate of water vapor transmission per unit area per unit of vapor pressure differential under test conditions.  It is an index of the ability of materials barrier water vapor.  Higher water vapor transmission rate, poorer water vapor barrier property, shorter shelf life of products 47
  48. 48.  Temperature and Relative Humidity (RH) Controlled Chambers 48
  49. 49. OXYGEN TRANSMISSION RATE  Is the steady state rate at which oxygen gas permeates through a film at specified conditions of temperature and relative humidity.  Value is expressed in cc/100 in2/24 hr in US standard units and cc/m2/24 hrs. in metric (or SI) units. 49
  50. 50. BLISTERSCAN  Blisterscan (SEPHA industries), a laser- based leak detection machine, test method detected 100% of 15μm sized holes, while only 85% of such defects were picked up by blue dye testing. 50
  51. 51. BROOKFIELD CT3 ANALYZER The TA-BPS has been developed to calculate the force needed to push the pill through a blister pack. The V2 inch radius Finger Probe, replicating a human finger, is pushed down onto the tablet at a steady speed, forcing the tablet through the foil. Peak load is the main information from this test which is the maximum force noted during the probe’s descent on the package. Strength of the blister pack . 51
  52. 52. 52
  53. 53. PACKAGING DEVELOPMENT  Objective  To ensure timely and robust selection of the primary pack for clinical trial and commercial supply.  Recommended approach:  To use, where possible, a limited range of standard, well-characterised pack materials and packs.  To ensure thorough testing, characterisation and understanding of these selected pack materials and packs. 53
  54. 54. COMMERCIAL PACK DEVELOPMENT  Approach: 3. Development Stability Testing 2. Material Selection & Testing 1. Identify Pack Options 5. Pack Selection 4. Controls Defined 54
  55. 55. CASE STUDY:  Product: Amoxicillin-clavulanic acid tablets  59 samples were collected from 48 medicine outlets.  Samples were classified into five types according to package type and the presence of desiccants (e.g., silica gel) 55 Type A Press-through packaging (PTP) of aluminium- aluminium materials in cardboard boxes. Type B Type A tablets wrapped in transparent plastic with silica gel. Type C Type A tablets wrapped in aluminium with silica gel. Type D Similar to Type C, but with PTP made of an aluminium-plastic composite. Type E Strip packaging (SP) in cardboard boxes without silica gel.
  56. 56.  A stability test was conducted on amoxicillin/clavulanic acid at 37 C with 100% relative humidity (RH).  They used one control sample with no visible defect, one with torn wrapping but no strip defect, and one in which the strips were deliberately perforated.  In all three samples, amoxicillin and clavulanic acid contents were measured at 0, 24, 48, 72, and 96 hours.  8 failed dose requirements  10 content uniformity and 20dissolution tests 56
  57. 57. 57
  58. 58. DISCUSSION  Interestingly, clavulanic acid accounted for most failures in the quantity and content uniformity tests (87.5% and 70% of failures, respectively), whereas amoxicillin accounted for most failures (80%) in the dissolution tests.  Clavulanic acid is volatile and unstable when exposed to high temperatures and high pH.  In addition, clavulanic acid is hygroscopic; therefore, 30% RH or less is desirable for storage  Samples that failed the content uniformity test usually came from open packages/containers during sampling 58
  59. 59. SUMMARY  Packaging is one of the most important part of pharmaceutical industries  Quality maintenance is measure role played by packaging material  Along with that it gives pharmaceutical elegance and convenience to user to product  Many a times the packaging may become a ideal unique identification for some of brand in market  Quality control of such important part is also a vary valuable work 59
  60. 60. REFERENCES.  Ambrosio TJ. Packaging of pharmaceutical Dosage forms. In: Gilbert S Banker & Christopher T Rhodes, editor. Modern Pharmaceutics. 3rd ed. Florida: Taylor and Francis group;1996. P. 483-485. (Drugs and the Pharmaceutical Sciences; vol 72)  Dean D.A. Blister, Strip and Sachet Packaging Evans E.R, Hall I.H. editors, Pharmaceutical Packaging Technology, 11 New Fetter Lane, London 2005. P. 370.  Ebewele RO. Chapter Four Thermal Transitions in Polymers, Polymer Science And Technology, P. 553 CRC Press Boca Raton New York 60
  61. 61. REFERENCES.  Yam KL. Editor,Encyclopedia Of Packaging Technology, Third Edition, A John Wiley & Sons, Inc., Publication 2009, P 464-465.  Lachman L, Liberman HA, Packaging Material Science, The Theory and Practice of Industrial Pharmacy, CBS Publishers,2009 P 711-733.  http://www.ask.com/question/what-is-blister- packaging ( last accessed on 14-04)  Pilchik R, Pharmaceutical Blister Packaging, Part I, Rationale and Materials, Pharmaceutical Technology NOVEMBER 2000.  http://pharma.financialexpress.com/20040624/techn ologytrendz01.shtml ( last accessed on 18-04) 61
  62. 62. REFERENCES.  http://www.amcor.com/products_services/BLISTER _LIDDING.html ( last accessed on 14-04)  http://formulation.vinensia.com/2012/01/glass-for- pharmaceutical-packaging-and.html ( last accessed on 17-04)  http://www.azom.com/article.aspx?ArticleID=8034 ( last accessed on 21-04)  ―INDIAN PHARMACOPOEIA 2007‖, Volume-1, published by The Indian Pharmacopoeia Commission, Central Indian pharmacopoeia Laboratory Govt. Of India, Ministry of Health & Family Welfare Sector-23, Raj Nagar, Ghaziabad-201 00 Page no. 363-371  ―UNITED STATES PHARMACOPOEIA 2007‖,Volume-1,Page no.661 62
  63. 63. REFERENCES.  Khan MH,Hatanaka K. Effects of packaging and storage conditions on the quality of amoxicillin- clavulanic acid – an analysis of Cambodian samples, BMC Pharmacol Toxicol. 2013; 14: 33. 63
  64. 64. Than k you 64
  65. 65. 65

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